For our GSPV department, we are looking for a
Head of QPPV Office and PV Intelligence (m/f/x)
R-233736
Fulltime / permanent / non-tariff
The Opportunity
As Head of QPPV Office and PV Intelligence you will be responsible for the direction and management of the QPPV office team and the PV Intelligence function to ensure accurate descriptions are in place of CSL’s Pharmacovigilance system (the EU-Pharmacovigilance System Master File (PSMF)) and at national levels in compliance with applicable legislative requirements. In addition, the role oversees applicable PV regulations globally, leads the impact assessment of new/revised PV legislation on existing safety processes and is responsible for end-to-end oversight of such changes to the QPPV to support compliance of the GSPV function at a global level
The Role
1. Your main responsibility in this role will be to maintain and further develop the EU-PSMF as required in EU legislation as well as the UK PSMF as required in the UK legislation
2. You will oversee content of local PSMFs/Pharmacovigilance Sub-System Files (PSSFs) and ensure alignment with the EU-PSMF
3. Another focus for you will be to ensure compliance of CSL’s PV system with changes in the global regulatory environment by leading an end-to-end process for legislative changes related to PV including impact assessments and functional implementation of process changes where required
4. You will lead and develop a team of Pharmacovigilance professionals in line with departmental and company objectives and will act as SME during Health Authority inspections and support inspection readiness
Your Skills and Experience
5. Master’s degree in sciences (e.g., Medicine, Pharmacy, etc.)
6. 10+ years Pharmacovigilance experience in multinational pharmaceutical industry
7. SME of PSMF/local PSMF/PSSF and applicable legislation/guidelines
8. Broad understanding of the global PV system, its quality system, and the dependencies of PV activities across the company
9. Expert knowledge of international standards and regulatory requirements/ regulations and processes related to pharmacovigilance including GCP related Pharmacovigilance
10. Experience in project-management, CAPA and SOP development
11. Experience in people management
What we offer
12. Innovative work-environment at our
13. CSL-subsidized company bike leasing
14. Childcare “Kita Froschkönig” for up to 14 children (from 6 months till 3 years old)
15. Access to Gym facility on campus
16. 2 Wellness days per year (additional paid time off)
17. Family services such as psychological support, legal advisory, family care services and more for you and your direct family